Feasibility and Effectiveness of a Personalized Home-Based Motor-Cognitive Training Program in Community-Dwelling Older Adults: Protocol for a Pragmatic Pilot Randomized Controlled Trial (Preprint)

Author:

Seinsche JuliaORCID,de Bruin Eling DORCID,Saibene EnricoORCID,Rizzo FrancescoORCID,Carpinella IlariaORCID,Ferrarin MaurizioORCID,Ifanger SarinaORCID,Moza SotiriaORCID,Giannouli EleftheriaORCID

Abstract

BACKGROUND

Exergame-based motor-cognitive training in older adults has been associated with improvements in physical, cognitive, and psychological functioning. The novel Cocare system (Dividat GmbH), developed through a user-centered design process, allows motor-cognitive training in a telerehabilitation setting. It includes (1) a stationary stepping platform for supervised exergame training (Dividat Senso; Dividat GmbH), (2) a home-based version (Dividat Senso Flex, which is a rollable pressure-sensitive mat; Dividat GmbH), (3) an assessment system (including motor-cognitive tests), and (4) a rehabilitation cockpit for remote training supervision and management.

OBJECTIVE

The aim of this study is to test the feasibility and effectiveness of this novel training system.

METHODS

A total of 180 older adults from Switzerland, Italy, and Cyprus aged ≥60 years with a prescription for rehabilitation are randomly allocated to an intervention group or a control group. Both groups continue with their usual care, whereas participants in the intervention group additionally perform a 2-week supervised exergame training program at rehabilitation centers, followed by a 10-week home training program under remote supervision. The assessment system is used to indicate the start level of each participant, and, in both intervention periods, standardized progression rules are applied. The measures of feasibility include adherence, attrition, exergame enjoyment, willingness to perform such a training program, and the number and types of help requests. Effectiveness is assessed in terms of cognitive and physical functioning, balance confidence, and quality of life.

RESULTS

Data collection started in February 2023 and is ongoing. Final measurements are expected to be performed in January 2024.

CONCLUSIONS

Owing to the user-centered design approach, the Cocare system is expected to be user-friendly and offers several novel features to cover the whole continuum of care. This pragmatic trial will provide valuable information regarding final necessary adaptations and subsequent implementation efforts.

CLINICALTRIAL

ClinicalTrials.gov NCT05751551; https://www.clinicaltrials.gov/study/NCT05751551

INTERNATIONAL REGISTERED REPORT

DERR1-10.2196/49377

Publisher

JMIR Publications Inc.

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